S. Korea approves Phase III trial of SK Bioscience’s COVID-19 vaccine

Aug 11, 2021, 09:07 am

		0
Minister of Food and Drug Safety Kim Gang-lip announces at the media briefing that the government has approved SK Bioscience to conduct the phase three clinical trial of its COVID-19 vaccine candidate, GBP510, at the ministry in Cheongju on August 10, 2021./ Source: Yonhap

AsiaToday reporters Kim Si-young & Park Ah-ram

As various countries are competing to develop COVID-19 vaccines amid the pandemic, South Korea kicked off clinical trials that would bring localization of South Korean vaccines and vaccine sovereignty. The Ministry of Food and Drug Safety (MFDS) approved phase III clinical trial of SK Bioscience’s COVID-19 vaccine candidate, which is expected to accelerate the development of domestic vaccines.

The MFDS announced Tuesday that it has approved SK Bioscience to conduct the phase three clinical trials of its COVID-19 vaccine candidate GBP510 after verifying the safety and scientific validity of the clinical trial plan. “We have carefully reviewed the GBP510 clinical trial plan based on scientific evidence, putting the safety of the subjects first,” the MFDS said.

GBP510 is the country’s first indigenous COVID-19 vaccine candidate to enter the final phase of clinical trial. SK Bioscience targets to commercialize the vaccine within the first half of 2022.

GBP510 is a recombinant vaccine that injects surface antigen protein of the coronavirus made using genetic recombination technology to induce an immune response. This vaccine has been developed to enhance immune effects by generating antibodies by utilizing techniques that increase antigen exposure.

The last phase of clinical trials is conducted in a comparative clinical manner that demonstrates effectiveness through comparison with existing licensed vaccines. It marks the second time in the world for such a comparison trial to be conducted. The clinical trial will compare GBP510 against AstraZeneca’s COVID-19 vaccine. It will be simultaneously held in different countries by injecting three thousand of the 3,990 adults receiving the experimental vaccine and the remaining 990 getting AstraZeneca doses.

The final phase clinical trials confirm the safety and efficacy of clinical drugs, whose feasibility is reviewed based on the results of previous clinical trials as well as non-clinical and quality data of the clinical drug. The MFDS explained that GBP510 is currently undergoing the phase II clinical trial, but its safety and immunogenicity have been sufficiently confirmed in the phase I, demonstrating the possibility of entering a phase III clinical trial.

Following the approval of the first and second phase trials, the first phase trial was conducted on 80 adults. The second phase trial is underway with 240 participants. SK Bioscience said that data from first trials of 80 participants showed they all induced neutralizing antibodies against the virus. No special side effects have been reported except for injection site pain, fatigue, and muscle pain, which are commonly seen during vaccination, according to the company.

SK Bioscience aims to complete vaccine development by conducting clinical trials without any setbacks through international cooperation. The development is funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI). The two organizations have funded up to $213.7 million since the initial development stage.

The global part of the third phase trial will be conducted in partnership with the International Vaccine Institute (IVI) in multiple countries located in Europe and Southeast Asia. SK Bioscience will apply for the World Health Organization’s prequalification (PQ) program and prepare to file for emergency use approvals in a number of countries.

GBP510 was selected as the first target of support for the Wave2 (next-generation COVID-19 vaccine) project aimed to support a group of differentiated COVID-19 vaccine candidates. When commercialized, it will be supplied worldwide through the COVAX facility.

“We will quickly develop a vaccine that guarantees safety and effectiveness, and we will contribute to efforts around the world to get back to our routine life,” SK Bioscience CEO Ahn Jae-yong said.

#SK Bioscience #COVID-19 #phase iii #GBP510